Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy

Completed

Conditions studied: Cardiomyopathies, Gender, Implantable Defibrillator User

In brief

The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.

Key facts

Study ID

NCT03884608

Run by

Biotronik, Inc.

People needed

1000

Starts

2019-05-09

Expected to finish

2024-11-19

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
• Patient has non-ischemic etiology of cardiomyopathy
• Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
• Patient is able to understand the nature of the study and provide informed consent
• Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
• Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
• Patient age is greater than or equal to 18 years

You may not qualify if…

• Patient meets secondary prevention ICD indication
• Patient has ischemic etiology of cardiomyopathy
• Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
• Patient is expected to receive heart transplantation or ventricular assist device within 1 year
• Patient life expectancy is less than 1 year
• Patient reports pregnancy at the time of consent

Where it is running

• Southview Cardiovascular Associates — Birmingham, Alabama, United States
• Cardiology Associates of Mobile — Fairhope, Alabama, United States
• Eisenhower Desert Cardiology — Rancho Mirage, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Cardiovascular Institute of North Colorado — Greeley, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• BayCare Medical Group Cardiology — Safety Harbor, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Saint Alphonsus Heart Care — Boise, Idaho, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Traverse Heart and Vascular — Traverse City, Michigan, United States
• Metro Health Hospital — Wyoming, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Cardiology Associates Research — Tupelo, Mississippi, United States
• Mercy Clinic Heart and Vascular — St Louis, Missouri, United States
• Logan Health Research — Kalispell, Montana, United States
• NYP Brooklyn Methodist Hospital — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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